New study results also show evidence of additional protectionagainst ...LOS ANGELES April 17 2007 /PRNewswire-FirstCall/ -- TheGlaxoSmithKl...The GSK cervical cancer candidate vaccine also showed 68 percentvacci... These new data from this extended follow-up trial are excitingfor th...Additionally the trial found that the candidate vaccine induceda str...

New study results also show evidence of additional protection
against infection with other cancer-causing virus types

LOS ANGELES, April 17, 2007 /PRNewswire-FirstCall/ -- The
GlaxoSmithKline cervical cancer candidate vaccine, CERVARIX(R),
demonstrated 100 percent efficacy in preventing precancerous
lesions due to cancer-causing human papillomavirus types 16 and 18
for up to 5.5 years in an extended follow-up trial, according to
data presented today at the American Association for Cancer
Research. The trial results demonstrate the longest duration of
protection seen in any cervical cancer vaccine trial reported to
date.

The GSK cervical cancer candidate vaccine also showed 68 percent
vaccine efficacy against precancerous lesions (CIN2+) and 38
percent vaccine efficacy against abnormal Pap smears, regardless of
the type of cancer-causing virus detected. These results suggest
evidence of protection beyond what might be expected from a vaccine
that is designed to target virus types 16 and 18 alone. More
specifically, the study confirmed that the candidate vaccine
provides further preliminary evidence of cross-protection against
incident infection with cancer-causing virus types 45 and 31 that
also extended up to 5.5 years after vaccination.

"These new data from this extended follow-up trial are exciting
for those of us who are working to prevent cervical cancer, and for
women around the world," said Dr. Stanley Gall, lead investigator
and Professor of Obstetrics, Gynecology and Women's Health at the
University of Louisville, Kentucky. "Demonstrating 100 percent
efficacy and sustained immune response for more than five years is
a significant contribution to the scientific understanding of
preventing cervical cancer and precancerous lesions through
vaccination."

Additionally, the trial found that the candidate vaccine induced
a strong immune response in virtually 100 percent of women in the
stud
y, which was maintained over 5.5 years for both virus types 16
and 18. At the end of the 5.5 year observation period, the average
level of antibodies against both virus types 16 and 18 was at least
11 times greater than antibody levels associated with natural
infection with the virus.

"The results of this study confirm our confidence in our
cervical cancer candidate vaccine, which includes a novel
proprietary adjuvant system, called AS04, intended to enhance
immune response and increase duration of protection," said Dr.
Hugues Bogaerts, Vice President of Worldwide Medical Affairs, Human
Papillomavirus Vaccines, GSK. "We believe that the best possible
prevention of cervical cancer will include routine screening
together with a vaccine designed to provide broad and durable
protection against the most common cancer-causing virus types."

Notes to editors

About the study

This was an extended follow-up (EFU) analysis of women who
participated in the initial efficacy study of GSK's cervical cancer
candidate vaccine. The initial study was a double-blind, controlled
trial of 1,113 young women between 15-25 years of age, randomized
to receive three doses of the GSK candidate vaccine for cervical
cancer formulated with the AS04 adjuvant system, or three doses of
placebo on a 0, 1 and 6 month schedule.

This extended follow-up study looked at study endpoints for 776
women from the same cohort of women for a period of up to 67
months. The trial was conducted in 28 centers in Brazil, Canada and
the U.S. and evaluated the efficacy, safety and immunogenicity of
GSK's cervical cancer candidate vaccine for the prevention of
infection with cancer causing virus types 16 and/or 18, and other
cancer-causing virus types, as well as associated Pap smear
abnormalities and cervical precancerous lesions. In the extended
follow up study, women were evaluated for the presence of human
papillomavirus DNA by PCR using cervical samples and annual
cervical cytology
evaluations were performed. Women were referred
for colposcopy following protocol guidelines. Women were also
assessed for long-term immunogenicity and safety.

About cervical cancer and its progression

Approximately 100 types of human papillomavirus have been
identified to date and, of these, approximately 15 virus types are
considered to cause cervical cancer. Virus types 16, 18, 45 and 31
are responsible for approximately 80 percent of cervical cancers
globally. Persistent infection with a cancer-causing virus type
leads to the formation of abnormal cells in the cervix, which, over
time, may become precancerous or cancerous. Throughout their
lifetime, women may be exposed to cancer-causing virus types and
are potentially at risk of developing cervical cancer.

Globally, cervical cancer is the second leading cause of cancer
death among women 20-39 years of age after breast cancer.

The GSK Cervical Cancer Candidate Vaccine Around the World

In addition to the Biologics License Application submitted for
CERVARIX(R) with the U.S. Food and Drug Administration, GSK has
submitted a marketing authorization application to the European
Medicines Agency, Australia, Canada, and major countries in Asia
and Latin America.

About GlaxoSmithKline

GlaxoSmithKline-one of the world's leading research-based
pharmaceutical and healthcare companies-is committed to improving
the quality of human life by enabling people to do more, feel
better and live longer. For company information, please visit
www.gsk.com/media.

GSK Biologicals (GSK Bio), one of the world's leading vaccine
manufacturers, is headquartered in Rixensart, Belgium, where the
majority of GlaxoSmithKline's activities in the field of vaccine
research, development and production are conducted. GSK Bio employs
more than 1,500 scientists, who are devoted to discovering new
vaccines and developing more cost-effective and
convenient
combination products to prevent infections that cause serious
medical problems worldwide. In 2006, GSK Bio distributed more than
1.1 billion doses of vaccines to 169 countries in both the
developed and the developing world - an average of 3 million doses
a day. Of those vaccine doses, approximately 136 million were doses
of combination pediatric vaccines which protect the world's
children with up to six diseases in one vaccine.

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